NCT01477931已完成4 期
An Open-Label, 8-week Trial of Bupropion Hydrochloride Extended Release (Wellbutrin XL®) In Patients With Major Depressive Disorder (MDD) With Atypical Features.
Chi-Un Pae6 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- HAM-D-29 scores(Hamilton Depression Rating Scale 29)
研究概览
简要总结
The aims of this study are 1) to examine the clinical utility of bupropion hydrochloride extended release (Wellbutrin XL®) in patients with Major Depressive Disorder (MDD) with atypical features; 2) to evaluate the tolerability of bupropion hydrochloride extended release (Wellbutrin XL®) in patients with MDD with atypical features.
详细描述
Whether bupropion hydrochloride extended release (Wellbutrin XL®) improved atypical depressive symptoms has not been investigated. The investigators assumed that bupropion hydrochloride extended release (Wellbutrin XL®) will be effective and tolerable in the treatment of atypical depression in MDD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 20 years
- •DSM-IV episode of MDD non-psychotic with atypical features characterized by mood reactivity and 2 or more symptoms of vegetative reversal (including overeating, oversleeping, severe fatigue or leaden paralysis, and a history of rejection sensitivity)
- •More than 19 score on the 29-item HAM-D
- •Ability to give informed consent
排除标准
- •Bipolar depression
- •Any Axis I psychotic disorder
- •A history of suicide attempt, self-injurious action (excluding action with no intention of suicide) or overdosage (excluding apparently accidental overdosage)
- •Patients with more than 3-point score of suicide (HAM-D-29 Item 18) or patients whose C-SSRS assessment suggests that they are or have been at significant risk for harming themselves or have actually harmed themselves, or who, in the opinion of the investigator (sub-investigator), are at significant risk for harming self or others
- •A history of substance abuse in the previous 12 months
- •A history of hypersensitivity to bupropion or any other components of the preparations used in the study (Wellbutrin SR 150mg and Wellbutrin XL 300 mg tablets)
- •Serious or unstable medical disorders
- •Starting or terminating psychotherapy during the previous 12 weeks,
- •ECT treatment in the previous 3 months
- •Subject has a life time diagnosis of anorexia nervosa or bulimia within the past 12 month
- •Subject has a current or history of seizure disorder or brain injury (traumatic or disease-related) or any condition which predisposes to seizure- subject treated with other medications or treatment regimens that lower seizure threshold- subject undergoing abrupt discontinuation of alcohol or sedatives
- •Subjects that previously failed adequate courses of pharmacotherapy from two different classes of antidepressants or previous adequate course(s) of bupropion
- •Pregnancy or planning pregnancy - when a patient is in active reproductive age, he or she has to agree to use relevant contraception during the study
- •Patients on monoamine oxidase inhibitors (MAOIs)
- •Patients being treated with any other preparations containing bupropion as the incidence of seizures is dose dependent
研究组 & 干预措施
Wellbutrin XL
Experimental
干预措施: Bupropion extended release (Drug)
结局指标
主要结局
HAM-D-29 scores(Hamilton Depression Rating Scale 29)
时间窗: 8 weeks
Changes in HAM-D-29 scores from baseline to the end of treatment.
次要结局
- 8-atypical items on the HAM-D-29(8 weeks)
- Tolerability(8 weeks)
- CGI-I score(Clinical Global Impression Improvement score)(8 weeks)
- SDS(Zung Self-Rating Depression Scale)(8 weeks)
- C-SSRS(The Columbia-Suicide Severity Rating Scale, changes in behaviours and ideation)(8 weeks)
- ESQ(Epworth Sleepiness Questionnaire)(8 weeks)
- Response(8 weeks)
- Remission(8 weeks)
研究者
Chi-Un Pae
Chi-Un Pae MD, phD, Department of Psychiatry
The Catholic University of Korea
研究点 (6)
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